Regulatory Specialist

Job Description:

Prepare, distribute, and track regulatory submissions including, drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), ensuring compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations. Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA) and other Health Authorities. Attend scientific meetings and reviews the literature to stay current with new developments in the infectious disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB)) and therapeutic clinical research. Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.

Job Requirements:

Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well. Ability to analyze medical research data and review experimental protocols. Strong working knowledge of Microsoft office; experience with SharePoint a plus. Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus. Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards. This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.